Decontamination Tech 2

Hologic•Marlborough, MA

12d•$45,400 - $68,100•Onsite

About The Position

Under general supervision, perform testing, inspection, rework, decontamination, and assembly activities in accordance with assembly drawings, schematics, work instructions, and quality procedures. The incumbent will operate within a regulated medical device manufacturing environment and maintain compliance with ISO 13485, FDA 21 CFR Part 820, GMP, and applicable regulatory requirements.

Requirements

High School Diploma or equivalent required.
Ability to use common manufacturing and testing tools including screwdrivers, wrenches, torque tools, crimpers, soldering irons, multimeters, and oscilloscopes.
Ability to read and follow written procedures, work instructions, engineering drawings, and quality documentation.
Strong computer skills, including spreadsheet applications and electronic data entry systems.
Effective verbal and written communication skills.
Ability to work independently with minimal supervision while managing multiple priorities.
Strong attention to detail and commitment to producing high-quality work.
Demonstrated problem-solving and continuous improvement mindset.
Ability to sit, stand, walk, bend, and lift materials throughout the workday.
Ability to lift and move materials weighing up to 25 pounds.
Ability to wear required PPE and work safely with decontamination equipment and materials.
Ability to work in a Clean Room environment and adhere to gowning requirements when applicable.

Nice To Haves

Technical Degree or Trade School certification in Electronics Technology or a related discipline preferred.
Equivalent combination of education and relevant work experience will be considered.
Minimum of three (3) years of manufacturing experience, including assembly, testing, inspection, and shipment of products preferred.
Experience in a regulated medical device, biotechnology, pharmaceutical, or healthcare manufacturing environment preferred.
Proficient in Microsoft Office applications; experience with Oracle, Agile, or similar ERP/MRP systems preferred.
Working knowledge of GMP, ISO 13485, FDA Quality System Regulations, and medical device manufacturing practices preferred.

Responsibilities

Operate equipment used in the decontamination process for all products returned to Hologic.
Properly clean and decontaminate returned products using required personal protective equipment (PPE) while following established procedures and safety protocols.
Inspect, test, rework, and assemble products and subassemblies as required.
Communicate daily with cross-functional departments regarding production priorities, material disposition, and operational requirements.
Support process validations and recommend continuous improvement initiatives across multiple departments.
Adhere to 6S workplace organization standards and maintain a clean, safe, and organized work environment.
Verify that calibrated equipment is within specification and suitable for use.
Perform routine equipment maintenance and preventative maintenance activities as required.
Accurately complete manufacturing documentation and records in accordance with GMP requirements.
Work effectively in a team-based manufacturing environment.
Operate within a controlled Clean Room environment when required.
Understand and comply with all safety regulations, quality requirements, and company policies.
Support special projects and departmental initiatives as assigned.
Work overtime as needed to meet decontamination and production schedules.